Health Ministry Bars Import of Drugs With Less Than One Year of Residual Shelf Life
New Delhi: The Ministry of Health and Family Welfare (MoHFW) has amended Rule 31 of the Drugs Rules, 1945, to prohibit the import of drugs with less than one year of residual shelf life on the date of import, while allowing biological drugs and radiopharmaceuticals to be imported with 60% of their labelled shelf life remaining.
Under the revised provision, the licensing authority shall not permit the import of drugs having less than one year of residual shelf life on the date of import, while biological drugs and radiopharmaceuticals may be allowed with 60% of their labelled shelf life remaining.
The amendment has been introduced through the Drugs (Thirteenth Amendment) Rules, 2026, vide Gazette Notification G.S.R. 951(E), dated October 16, 2026. Published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), dated October 28, 2026, the rules take effect from the date of their publication in the Official Gazette.
As per the notification, the Ministry has replaced the second proviso to Rule 31 of the Drugs Rules, 1945. The substituted provision sets a minimum residual shelf-life requirement of one year for imported drugs, with a separate percentage-based provision for biological drugs and radiopharmaceuticals.
For biological drugs and radiopharmaceuticals, the notification provides that 60% of the labelled shelf life may be allowed. The wording makes this a permission available under the provision, rather than an unconditional entitlement to import.
The amendment follows the publication of draft rules through notification G.S.R. 505(E), dated June 22, 2026. The draft was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from persons likely to be affected by the proposed changes.
Stakeholders were given thirty days to submit their objections and suggestions, calculated from the date on which copies of the Gazette containing the draft notification were made available to the public. According to the final notification, those copies became publicly available on June 25, 2026.
The Ministry stated that the Central Government considered the objections and suggestions received from the public before finalising the amendment.
The rules have been framed in exercise of the powers conferred by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board (DTAB). The notification also records that the draft publication was undertaken as required under sub-section (1) of Section 12 and sub-section (1) of Section 33 of the Act.
The notification was issued by the Department of Health and Family Welfare under file number X.11014/08/2026-DR and signed by Pushpendra Rajput, Joint Secretary.
According to the accompanying note, the Drugs Rules, 1945 were originally published through notification F. 28-10/45H (1), dated December 21, 1945, and were last amended before this notification through G.S.R. 713(E), dated August 6, 2026.
The notification states:
Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely: —1. (1) These rules may be called the Drugs (Thirteenth Amendment) Rules, 2026.(2) These rules shall come into force on the date of their publication in the Official Gazette.2. In the Drugs Rules, 1945, in rule 31, for the second proviso, the following proviso shall be substituted, namely:-“Provided further that the licensing authority shall not allow the import of any drug having less than one year residual shelf-life period as on the date of import and in case of biological drugs and Radiopharmaceuticals, Sixty percent of the labelled shelf-life may be allowed:”.
To view the official notice, click the link below:
